In Europe, information about this analysis was placed into the approved product labeling for Avandia.
Positive will be moved to the FDA approved product for drug follow up.
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Depomed also has a phase III product that is aiming to become the first FDA approved product for hot flashes.
What if a company develops an improvement to an FDA-approved product?
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LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.
In addition to current strategies, it will be crucial to deliver a step-change in the demonstration of value to payers and patients to ensure that every approved product reaches its full potential.
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Working with U.S. Army and Defense Information Systems Agency (DISA) sponsors and partners, BlackBerry 7 smartphones have undergone successful testing through Army labs leading to a subsequent listing on DISA's Unified Communications Approved Product List (UCAPL).
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The FDA has approved this product for OTC use, and some have gained relief from this product.
The Senate Commerce, Science and Transportation Committee approved a product liability bill (S648) in May 1997, similar to the legislation vetoed by Clinton in 1996.
Allison Zieve, a lawyer for Public Citizen, argued that even if the FDA approved the product, a jury could decide whether it was unreasonably dangerous.
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The bottom line is that for the time being, from a regulatory perspective each biosimilar version of an approved biological product will be regarded as, in effect, a completely new and distinct drug.
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It plans one for the stent product that it hopes will be approved in 2014 and another for the interstitial cystitis product expected to be approved in 2015.
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The FDA has approved only one product, ATryn, an anticoagulant derived from the milk of transgenic goats.
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And we must tackle the really tough regulatory issues so a product approved on one side of the Atlantic can immediately enter the market on the other.
Pop quiz: when a drug company finally gets a product approved after spending years and hundreds of millions of dollars on research, what does its stock do?
With successful conclusion of this Phase III clinical program, LibiGel could be the first product approved by the FDA for women with low sexual desire, HSDD, a significant unmet medical need.
Amid disputes whether the late Steve Jobs would have approved of the product, WSJ.com reported that LG Display and AU Optronics began mass production of what will be the 7.85-inch liquid crystal display.
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The company blamed the weak quarter on delays at some customers in getting deals approved, and a product transition in the hardware business.
Under these regulations, the manufacturer must conduct additional studies after the product is approved to demonstrate that the drug does, in fact, have a clinical benefit.
After that was ruled illegal in June, Guidant was left with few options: strike a deal with Boston Scientific, buy Cook, find a viable way around the ruling or sit out the market until its second-generation product was approved.
"Obviously, we thought when we acquired Coulter that this product would be approved last year, " Gillis says.
It can take eight months sometimes to get your product tested and approved.
Normally, these remain private correspondence even if a product is eventually approved.
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In other words, a no vote from an advisory panel is likely to stick, but a yes vote does not mean the product will be approved.
Rather, they are a product of deliberate decisions approved, we must assume, by the President himself.
Isis will pocket at least a third of the profits from the product if it is approved.
Food trucks will soon be required to have health department approved commissaries to prepare and store product.
And Pegasys is the only product in its class approved for use in patients who already have cirrhosis of the liver, meaning that nonfunctioning scar tissue has replaced normal liver tissue.
Acquiring raw materials or finished product outside of the FDA approved and highly regulated logistics chain is difficult, or is impossible.
Despite Scharf's advice to his mother, the product label the FDA has approved for Ambien suggests the drug be taken for no more than seven to ten days, and up to three weeks in certain cases.
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